NCT05505929

Brief Summary

This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.

Trial Health

83
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
8 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jun 2023Mar 2029

First Submitted

Initial submission to the registry

August 16, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

June 15, 2023

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2029

Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

5.6 years

First QC Date

August 16, 2022

Last Update Submit

March 2, 2026

Conditions

Post Market Clinical Follow up (PMCF)

Keywords

PMCFRegistryBiofreedom UltraeUltra

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure (TLF)

    12 months

Secondary Outcomes (5)

  • Clinically driven Target Lesion Revascularization (TLR)

    12 months

  • Cardiovascular death (CD)

    12 months

  • Target Vessel MI

    12 months

  • Target Vessel Revascularization (TVR)

    12 months

  • Stent thrombosis

    12 months

Interventions

Biofreedom UltraDEVICE

The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).

You may qualify if:

  • According to the current version of Instructions of Use (IFU)
  • Patient is at least 18 years old
  • Patient provides a signed informed consent

You may not qualify if:

  • According to current version of IFU
  • Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: "Clinical investigations on minors" and article 66: "Clinical investigations on pregnant or breastfeeding women"
  • Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Krankenhaus Barmherzige Brüder

Eisenstadt, Austria

RECRUITING

Clinique Des Domes Psr

Clermont-Ferrand, France

RECRUITING

Klinikum Lippe

Detmold, Germany

RECRUITING

Hospital Marques Valdecilla

Santander, Spain

RECRUITING

University and Hospital Fribourg

Fribourg, Switzerland

RECRUITING

Universitäres Herzzentrum

Zurich, Switzerland

RECRUITING

Military hospital

Tunis, Tunisia

RECRUITING

Al Qassimi Hospital

Sharjah city, United Arab Emirates

RECRUITING

Royal Bournemouth hospital

Bournemouth, United Kingdom

RECRUITING

Golden Jubilee National Hospital

Glasgow, United Kingdom

RECRUITING

Central Study Contacts

Calvin Bahr, MS

CONTACT

+41 21 804 80 24c.bahr@biosensors.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2022

First Posted

August 18, 2022

Study Start

June 15, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

March 30, 2029

Last Updated

March 4, 2026

Record last verified: 2026-03

Locations

GB(2)CH(2)AE(1)AU(1)DE(1)ES(1)TU(1)FR(1)